FDAClass IIDecember 11, 2013

Dimension Vista(R) 500 and Dimension Vista(R) 1500 recall: Software Issue

Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic…

Why was Dimension Vista(R) 500 and Dimension Vista(R) 1500 recalled?

There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801

Product
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
776
Distribution
Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
Recall date
December 11, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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